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WO2012126800A1 - Calcul d'une dose de médicament - Google Patents

Calcul d'une dose de médicament Download PDF

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Publication number
WO2012126800A1
WO2012126800A1 PCT/EP2012/054561 EP2012054561W WO2012126800A1 WO 2012126800 A1 WO2012126800 A1 WO 2012126800A1 EP 2012054561 W EP2012054561 W EP 2012054561W WO 2012126800 A1 WO2012126800 A1 WO 2012126800A1
Authority
WO
WIPO (PCT)
Prior art keywords
user
dose
physical activity
unit
medicament dose
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2012/054561
Other languages
English (en)
Inventor
Michael Schabbach
Jörg HEISIEP
Stephan MÜLLER-PATHLE
Ross Macarthur
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis Deutschland GmbH
Original Assignee
Sanofi Aventis Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Aventis Deutschland GmbH filed Critical Sanofi Aventis Deutschland GmbH
Priority to JP2013558438A priority Critical patent/JP6178243B2/ja
Priority to DK12709098.3T priority patent/DK2685898T3/da
Priority to EP12709098.3A priority patent/EP2685898B1/fr
Priority to CA2828077A priority patent/CA2828077A1/fr
Priority to US14/004,768 priority patent/US10105093B2/en
Publication of WO2012126800A1 publication Critical patent/WO2012126800A1/fr
Anticipated expiration legal-status Critical
Priority to US16/165,726 priority patent/US10506972B2/en
Ceased legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/22Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/221Ergometry, e.g. by using bicycle type apparatus
    • A61B5/222Ergometry, e.g. by using bicycle type apparatus combined with detection or measurement of physiological parameters, e.g. heart rate
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024Measuring pulse rate or heart rate
    • A61B5/02438Measuring pulse rate or heart rate with portable devices, e.g. worn by the patient

Definitions

  • the present invention relates to calculating a medicament dose.
  • the invention relates to a device for calculating a medicament dose and to a method of operating a device including calculating a medicament dose.
  • a "perfect glucose level” may mean that glucose levels are always in a range of 70 to 1 30 mg/dl or 3.9 to 7.2 mmol/l and/or undistinguishable from a person without diabetes.
  • blood glucose values are monitored once or several times during the day as relying on their own perception of symptoms of hyperglycemia or hypoglycemia is usually unsatisfactory as mild to moderate hyperglycemia causes no obvious symptoms in nearly all patients. If the blood glucose value is too high, e.g. over 130 mg/dl, insulin or insulin analogues can be administered.
  • long-acting basal insulin or insulin glargines which are long-acting basal insulin analogues
  • These insulin or insulin analogues are usually given once or twice daily to help control the blood sugar level of patients with diabetes.
  • the advantage of long-acting basal insulin or insulin glargine is that they have a duration of action of up to 24 hours or even more, and have a less peaked profile than NPH insulin.
  • the dose of basal insulin or insulin glargine has to be adjusted for each individual in accordance with a blood glucose level to be achieved.
  • the dose of insulin or insulin glargine is increased from an initial dose to a final dose over a certain time period until a specific blood glucose value, typically the fasting blood glucose (FBG) value, has reached the target range.
  • FBG fasting blood glucose
  • titration can be done by the health care professionals (HCPs).
  • HCPs health care professionals
  • the patient may be empowered and trained by the health care professionals to do their own titration.
  • Such a self-titration can be supported by an intervention from a third party support or services or some intermediate combination.
  • EP 1 281 351 A2 describes a diabetes management system which enables glycem ic control for a subject.
  • the described system includes an insulin delivery unit, a glucose sensor and a control unit.
  • the control unit includes a processor unit that receives glucose value readings from the glucose sensor, executes an algorithm that predicts a glucose value at a predetermined time in the future, compares the predicted glucose value with the predetermined glucose value range, and determines a corrective amount of insulin to be administered when the predicted glucose value lies outside of the predeterm ined glucose value range.
  • the glucose unit also includes a communication unit that transm its the corrective amount to the delivery unit.
  • WO201 0/089307 discloses a blood glucose meter that calculates a dose of e.g. insulin to be delivered to a user. An algorithm is used to calculate the dose based on a measured blood glucose level, user inputs and recent blood glucose levels. The calculated dose is displayed to the user.
  • a first aspect of the invention provides a device comprising:
  • means for obtaining a parameter of a sample of body fluid from a user means for using information provided by one or more sensors to calculate a measure of physical activity of the user;
  • the parameter may be a concentration of glucose.
  • the parameter may be another analyte parameter.
  • the parameter may be a concentration, although other parameters are not precluded.
  • the means for calculating the medicament dose may be configured to use also a measure of physical activity intensity to calculate the medicament dose.
  • the means for calculating the medicament dose may be configured to use also a time elapsed between an instance of physical activity and a current time to calculate the medicament dose.
  • the means for calculating the medicament dose may be configured to use also a duration of physical activity to calculate the medicament dose.
  • the means for calculating the medicament dose may be configured to integrate physical activity intensity with respect to time and to use the result of the integration to calculate the medicament dose.
  • the one or more sensors may include a pedometer and the measure of physical activity may be a number of steps taken by the user within a predetermined period.
  • the pedometer may be integrated with the device.
  • the one or more sensors may include an accelerometer integrated with the device.
  • the device may include a communications receiver configured to receive information from external one or more sensors.
  • the device may be configured to verify that information received using the communications receiver relates to a user registered with the device and to disregard information other than verified information when calculating the medicament dose.
  • the device may be configured to receive information relating to heart rate and/or blood pressure of a user and to calculate the measure of physical activity by processing the heart rate and/or blood pressure information.
  • the device may be configured to receive information relating to a number of steps taken by a user from an external pedometer and to calculate the measure of physical activity by processing the steps information.
  • the device may be configured to receive information relating to work done by the user or power exerted by the user from an external ergometer and to calculate the measure of physical activity by processing the work done or power information.
  • the means for obtaining a parameter may comprise blood glucose measurement means.
  • a second aspect of the invention provides a device comprising:
  • a receiver for obtaining a parameter of a sample of body fluid from a user; a calculator for using information provided by one or more sensors to calculate a measure of physical activity of the user and for calculating a medicament dose using at least in part the measured parameter and the measure of physical activity of the user;
  • an indicator for indicating the calculated medicament dose to the user.
  • a third aspect of the invention provides a method of operating a device, the method comprising:
  • Figure 1 is a schematic diagram of the medical device according to a preferred embodiment of the invention
  • Figure 2 is a flow diagram illustrating steps of operation of the medical device according to a preferred embodiment of the invention
  • Figure 3 is a flow diagram illustrating steps of a further operating procedure of the medical device according to a preferred embodiment of the invention.
  • Figure 4 is a flow diagram illustrating steps of another operating procedure of the medical device according to a preferred embodiment of the invention.
  • Figure 5 is another schematic diagram of the medical device shown in Figure 1 ;
  • Figure 6 is a flow diagram illustrating steps of the operating procedure shown in Figure 3 in further detail;
  • Figure 7 is a diagram illustrating detected physical activity plotted as activity intensity over a period of time
  • Figure 8 is a flow diagram illustrating steps of the operation procedure shown in Figure 2 in more detail
  • Figure 9 is a flow diagram illustrating steps of the operating process as shown in Figure 8 in more detail.
  • Figure 1 0 is another schematic diagram of the medical device shown in Figure 1 ;
  • Figure 1 1 is a schematic diagram illustrating the medical device according to another preferred embodiment of the invention;
  • Figure 12 is a schematic diagram illustrating the medical device according to another preferred embodiment of the invention.
  • Figure 1 3 is a schematic diagram illustrating the relation of the templates with the parameters and parameter sets according to embodiments of the invention.
  • FIG. 1 is a schematic diagram of the medical device according to a preferred embodiment of the invention.
  • the medical device 100 comprises a blood glucose measurement unit 1 1 0, which is arranged to measure the blood glucose level e.g. of the user of the medical device.
  • the blood glucose measurement unit 1 1 0 is connected to a receiving unit 120, which is arranged to forward e.g. blood glucose value data received from blood glucose measurement unit 1 1 0 to a storage unit 130.
  • the receiving unit may retrieve stored data such as e.g. blood glucose value data from the storage unit 130 and forward it to a determ ining unit 140.
  • the receiving unit 120 directly forwards the blood glucose value data received from the blood glucose measurement unit 1 10 to the determ ining unit 140.
  • Receiving unit 120 is further connected to user input unit 150.
  • the user input unit 1 50 is arranged to receive input from the user of the medical device 1 00.
  • the user input data are forwarded from the user input unit 150 to the receiving unit 120, which either forwards it to the determining unit 140 or to the storage unit 130.
  • the medical device 1 00 comprises a display unit 160, which is connected to the receiving unit 120.
  • the display unit 160 receives data to be displayed from the receiving unit 120.
  • the medical device 1 00 may additionally comprise a further interface 170, such as a USB interface, an IRDA interface, Bluetooth interface, etc. , in order to receive data and to transmit data.
  • the interface 170 is connected to the receiving unit 120 in order to receive data from the receiving unit 120 and to forward data to the receiving unit 120.
  • the medical device 100 includes one or more activity sensors 1 80 connected to the receiving unit 120 in order to provide sensor data to the determ ining unit 140.
  • the activity sensors 180 may include a pedometer that is configured to indicate a number of steps taken by the user.
  • the activity sensors 180 may include an accelerometer, for instance a microaccelerometer, that provides output signals indicative of movement of the sensor 180 and thus the medical device 1 00.
  • the one or more activity sensors 180 may instead take some other form.
  • the one or more activity sensors allow the medical device 1 00 to obtain a measure of physical activity of the user.
  • the medical device 1 00 comprises a blood glucose
  • the blood glucose measurement unit 1 10 is arranged to measure the blood glucose level in the blood of e.g. the user by testing a drop of blood on a respective test strip. The measured blood glucose value is then transformed to blood glucose value data and forwarded immediately or on demand to the receiving unit 120.
  • the blood glucose is measured by the blood glucose measurement unit 1 10 to measure the blood glucose level in the blood of e.g. the user by testing a drop of blood on a respective test strip.
  • the measured blood glucose value is then transformed to blood glucose value data and forwarded immediately or on demand to the receiving unit 120.
  • measurement unit 1 10 is arranged to measure the blood glucose level of e.g. the user via infrared diagnosis or an alternative contactless measurement method.
  • the blood glucose measurement unit 1 1 0 is implanted in the body of the user of the medical device 100 and forwards the data to the receiving unit 120 either via a wired connection or via a wireless
  • such an implanted blood glucose measurement unit 1 1 0 is a continuous measurement sensor e.g. based on a bio chip which allows a continuous closed loop control.
  • the blood glucose measurement unit 1 1 0 forwards the blood glucose measurement value data to the receiving unit 120 via interface 170.
  • the medical device 1 00 does not comprise a blood glucose measurement unit 1 1 0 which measures the blood glucose values, but receives blood glucose value data from an external unit.
  • the measurement of the blood glucose measurement is triggered by the receiving unit 120 which sends a respective signal to the blood glucose measurement unit 1 1 0.
  • the receiving unit 120 receives a trigger signal generated based on user input which is received via user input unit 150.
  • the trigger signal is generated automatically by a timer unit or by determining unit 140.
  • the receiving unit 120 is represented e.g. by the input ports and output ports of a microprocessor or a bus system managing the data handling between several functional units. This includes bus systems, such as e.g. Advanced Microprocessor Bus Architecture bus systems
  • the receiving unit 120 Via the receiving unit 120, data are retrieved from the storage unit 130 on demand and forwarded to the determ ining unit 140, to the display unit 160 or to the interface 1 70. Moreover, the receiving unit 120 forwards signals, such as trigger signals or control signals e.g. to the blood glucose measurement unit 1 1 0, the display unit 160 or the interface 170.
  • signals such as trigger signals or control signals e.g. to the blood glucose measurement unit 1 1 0, the display unit 160 or the interface 170.
  • the storage unit 130 is arranged to store data input via the user input unit 1 50, data received by the blood glucose measurement unit 1 10, data processed by the determ ining unit 140 and/or data received via interface 1 70. Furthermore, storage unit 130 is arranged to provide the stored data to the determ ining unit 140, to the display unit 160 and/or to the interface 170.
  • the storage unit 1 30 is implemented as a semiconductor memory. Alternatively, it is implemented as a hard disk memory or an on-chip memory of the determ ining unit 140.
  • the determining unit 140 is a microprocessor or any other functional unit capable of processing data.
  • the user input unit 1 50 may be implemented as one or more push buttons or alternatively as so called soft keys wherein the function of the respective soft key is displayed on the display unit 160.
  • the user input unit 1 50 is a key board or a touch screen.
  • the user input unit 150 comprises a m icrophone for receiving speech input so that data can be entered via speech input.
  • the display unit 160 comprises an LCD or LED display.
  • the display can display a number of alphanumerical characters so that e.g. the actual measured blood glucose value can be displayed together with additional instructions for the user.
  • the display unit 160 comprises a graphic display in order to display graphs or graphics.
  • the interface 1 70 is a wireless interface, such as IRDA, Bluetooth, GSM, UMTS, ZigBee, or WI-FI, etc.
  • the interface may be a wired interface, such as a USB port, serial port, parallel port, network card, etc. , for receiving and transmitting data.
  • the interface 1 70 may alternatively be om itted.
  • the medical device 1 00 comprises, additionally to the interface 1 70, a chip-card reader or a chip-card reader interface.
  • the chip- card reader is adapted to read a chip card, such as a SIM card or a chip card with information.
  • the chip card comprises a memory, wherein a selected algorithm together with corresponding parameters and a history of the blood glucose values and doses administered, etc. are stored.
  • the chip card may be used in order to provide information on the history of the treatment to e.g. an HCP.
  • a SIM card is used together with the chip-card reader of the medical device 1 00 and the interface unit 1 70 is additionally a mobile
  • the basic functions of the medical device 100 can be unlocked by the provider of the SIM card via a telecommunication channel.
  • the medical device 1 00 Via the international mobile subscriber identity, also called IMSI, stored in the SIM card, the medical device 1 00 identifies itself within a network and, thus, can be addressed via the network. In such a case the medical device 100 can be easily checked, remote controlled, updated, monitored, etc. , by addressing the mobile communication unit e.g. with a phone number.
  • the medical device 1 00 is able to transmit data via SMS, e-mail or via mobile internet connection.
  • the BG measurement unit 1 10 constitutes means for obtaining a parameter of a sample of bodily fluid from a user, for example a chem ical or biological parameter of a sample of bodily fluid.
  • the determining unit 140 constitutes means for using information provided by one or more sensors 120 to calculate a measure of physical activity of the user as well as means for calculating a medicament dose using at least in part the measured parameter and the measure of physical activity of the user.
  • the determining unit 140 and the display unit 160 constitute means for indicating the calculated medicament dose to the user.
  • the medical device 1 00 is capable to perform a number of operating processes.
  • the medical device 100 After switching on, the medical device 100 performs initialization step 21 0 for initializing the functional components of the medical device 1 00.
  • the different operation modes of which the medical device 100 is capable are displayed in the display step 220.
  • modes such as "Measure BG", "Output insulin dose”, “Mark event”, “Review history” and/or “Change settings” can be displayed in step 220.
  • the user selects one of the displayed operation modes via the user input unit 150.
  • the selected operation mode is executed.
  • steps 220 and 230 may be skipped in the case that a specific operation mode is preselected.
  • the preselected operation mode which is either preselected by the user or automatically selected in accordance with a specific event, the operating process proceeds with step 240 and executes the
  • the operation process may continue after the execution of the selected mode with step 220 in order to give the user of the medical device 1 00 the option to choose a further operation mode or the operation process ends. In the latter case the medical device 1 00 is switched off automatically.
  • One specific operation mode is the set up mode, which is also called change setting mode.
  • Figure 3 shows a schematic flow diagram of a preferred setup procedure.
  • the medical device 100 is adapted to measure a blood sugar level. Furthermore, it is arranged to review the history of the measured blood sugar. Preferably, the medical device 100 displays not only the recent blood glucose value data, but also the insulin dose adm inistered. Moreover, the medical device 1 00 and in particular the determining unit 140 determine e.g. a dose of insulin to be adm inistered based on specific parameters. Furthermore, the medical device 100 is arranged to receive data either via user input 1 50 or electronically via interface 1 70, which indicate specific events. Preferably, these functions or at least some of these functions can be adjusted to the needs of the user of the medical device 100. Figure 3 shows such a setup procedure for customizing the functions of the medical device 100 to determine the dose to be administered.
  • the setup procedure shown in Figure 3 provides step 310 for selecting an algorithm appropriate for the optimal glycemic control of the user's blood sugar.
  • step 310 either a
  • predefined algorithm is chosen or a new algorithm is defined.
  • the selected predefined or newly defined algorithm is stored or marked with an identifier, such as a flag or pointer, as the selected algorithm.
  • the selected algorithm is further personalized.
  • personalizing step 330 specific parameters of the selected algorithm can be further specified and/or selected in relation to the needs and requirements of the user of the medical device 1 00.
  • Figure 4 shows an alternative way for setting up the algorithm for determ ining the dose to be adm inistered.
  • This alternative setup procedure refers to algorithms which provide fewer options to be personalized and, thus, provide more
  • the starting dose or the current dose used by the user is input and stored in step 41 0.
  • the starting dose with which the user-directed titration is started is in the range of 10 to 20 units.
  • this dose or a dose equivalent to another insulin type is chosen in step 41 0 as the current dose.
  • a safety approach is taken in which the starting dose is set as a lower dose than the dose equivalent to the other insulin type.
  • step 420 a suitable algorithm is chosen and the algorithm is then stored in step 430.
  • storing of the selected algorithm does not necessarily require that the selected algorithm is stored additionally in the storage unit 1 30. Instead, the selected algorithm may be identified with an identifier such as a pointer or a flag which is stored in the storage unit 130 in relation to the selected algorithm.
  • Figure 5 shows a further schematic diagram of the medical device 1 00 according to a preferred embodiment of the invention.
  • Figure 5 shows details of the housing and the display of the medical device 1 00 according to a preferred embodiment of the invention.
  • the medical device 1 00 comprises housing 610 wherein in the upper side of the housing 610 the display unit 160 is placed.
  • the housing 61 0 shows a section wherein soft keys 620 and a navigation key 630 are placed.
  • the soft keys 620 are placed directly next to the display, preferably to the lower left and lower right side of the display.
  • the display can show the function actually assigned to the soft keys 620.
  • a soft key is a button located alongside the display unit 160. This soft key performs the function dependent on the text shown near it at the moment on the display.
  • the navigation key 630 is used for scrolling through the menu selections displayed in the display unit 160. Preferably, by pressing the upper part of key 630, one can scroll up the menu selections and by pressing the lower part of key 630, one can scroll to the lower part of the menu selections. Correspondingly, by pressing the left part of key 630, one can scroll to menu selections on the left side and when pressing the right part of key 630, one can scroll to the right part of the menu selections.
  • medical device 100 comprises a loudspeaker 640 connected to an acoustic module for outputting acoustic signals such as acoustic alerts or speech.
  • the medical device 100 also comprises a microphone 650 for speech input, voice recognition or for communicating via a network connection.
  • Figure 6 shows a flow diagram illustrating the steps of the operating procedure for selecting an algorithm as shown in Figure 3 in step 31 0. If it is decided in step 71 0 of the algorithm selection procedure to select a predefined algorithm , it is proceeded to step 720 in which a predefined algorithm is selected.
  • Step 720 may also include the selection of low FBG rules, hypoglycem ic rules and further intervention rules.
  • the substeps for defining a new algorithm are explained in further detail in regard to Figure 9.
  • the medical device 1 00 is configured to monitor physical activity of the user. This is achieved by the determ ining unit 140 analysing outputs of the one or more activity sensors 1 80 and storing representative data in the storage unit 130.
  • either the medical device 100 is active continually or alternatively is able to be woken from a sleep mode when activity occurs.
  • This can be achieved using the one or more activity sensors 1 80 themselves, particularly in the case of a gyroscope or accelerometer sensor. Waking of the medical device 1 00 from sleep mode when movement of the device is detected can be performed in any suitable way, for instance similarly to wakening in response to detection of movement used in some mobile phones, tablet computers etc.
  • the determ ining unit 140 is configured to store in the storage unit 130 information identifying the intensity of physical activity over time.
  • FIG. 7 data stored in the storage unit 1 30 by the determ ining unit 140 based on outputs of the one or more activity sensors 180 is illustrated.
  • time is shown on the horizontal axis and activity intensity is shown on the vertical axis.
  • the period shown in Figure 7 is from 6pm on one day to 6pm on the following day, although this is purely illustrative.
  • Figure 7 is a graphical illustration of the data stored in the storage unit 130. It shows that a first period 71 of relatively low intensity activity occurred from 7pm to 8pm. This first period 71 is shown to have a gradual increase from rest to a certain activity intensity, where the intensity remains the same for a period of time until the activity intensity reduces to zero relatively quickly.
  • the period of activity 71 might for instance be representative of the user taking a walk.
  • a second period of activity 72 is shown to start soon after 6am.
  • a relatively short period of relatively low intensity activity is followed by a period of relatively high intensity activity.
  • the transition from rest to low intensity is relatively quick, and the transition from low intensity activity to high intensity activity also is relatively quick.
  • the second period of activity 72 may be indicative for instance of the user walking to the gym then performing some intense physical exercise, for instance running on a treadm ill or using an exercise bike.
  • a third period of activity 73 occurs around m idday. This is shown in Figure 7 to be relatively short in duration.
  • a fourth period of activity 74 begins. This is shown to increase relatively gradually from rest to a relatively medium level of intensity, whereupon the intensity fluctuates for a period of approximately two hours before the intensity relatively quickly falls back to rest.
  • the fourth period of activity 74 m ight be indicative of the user undertaking some hill walking, a long cycle ride, or horse riding, for instance.
  • the determining unit 140 may determine an intensity of activity undertaken by the user in any suitable way.
  • the intensity of activity can be derived by the determ ining unit 140 by integrating the magnitude of the output of the accelerometer over time.
  • the output of the accelerometer 1 80 may be integrated over a period of some tens of seconds, for instance 30 seconds or 1 minute.
  • the intensity of the activity may simply be recorded as the elevation of the user's heart rate above their rest heart rate, or it may be provided using some more sophisticated calculation.
  • Providing a measure of activity intensity for a blood pressure sensor 1 80 can be performed in a similar way.
  • the use of a heart rate monitor in conjunction with a blood pressure detection device as the activity sensors 1 80 can provide a more reliable indication of intensity of activity undergone by the user.
  • the activity intensity may be derived from a step rate of the user.
  • a low step rate may indicate walking, and therefore be interpreted by the determ ining unit 140 as relatively low intensity activity.
  • a medium step rate may indicate slow jogging by the user, and a medium intensity activity inferred by the determining unit 140.
  • a high step rate may indicate fast jogging or running by the user, and the determ ining unit 140 may infer a relatively high intensity activity therefrom.
  • the determining unit 140 is configured to determ ine a level of intensity of activity in each of plural consecutive time periods and to record the intensity information along with an indication of the associated time period in the storage unit 1 30. For instance, the determining unit may determine activity intensity for periods of tens of seconds, 30 seconds, 1 m inute or 2 minutes, and record the result in data in the storage unit 130.
  • the smaller the time interval that is used by determining unit 140 the greater is the resolution of activity intensity monitoring and thus the more representative is the data of the users activity.
  • relatively small monitoring periods results in a larger amount of data being stored in the storage unit 130.
  • a relatively small monitoring period requires the storage unit 130 to comprise more memory.
  • a larger interval conversely, allows a smaller storage unit 1 30 to be used.
  • the medical device 100 also provides the function for measuring the blood sugar level, preferably in the blood of the user.
  • the medical device 100 also provides the function for measuring physical activity undergone by the user.
  • the measurement of the blood sugar level, also called blood glucose value, and the measure of physical activity is combined with the dose determination procedure as shown in Figure 8.
  • the blood glucose measurement procedure starts with a detection of whether the medical device 100 is in a titration mode or not. This detection is performed in step 1010. Whether the medical device 100 is in a titration mode or not is preferably detected automatically via parameters stored in the storage unit 130 or determined by the determining unit 140. Preferably, such a parameter is the titration interval or the time of day. In the case that the parameter is the titration interval and the titration interval is, for example three days, the medical device 100 is automatically in the titration mode if the last titration has been three days ago.
  • the medical device 100 is in the titration mode every morning. According to a further alternative, the medical device 100 is switched automatically to the titration mode based on a
  • the medical device 100 is automatically switched to the titration mode if the titration interval has passed and when the time of day is when the titration is usually performed.
  • the dose recommendation is given based on the previous FBG value and based on the previous measured or reported other blood glucose values.
  • a dose guidance is given even if no actual FBG value is available as long as this function is activated.
  • the medical device 100 is switched to the titration mode manually via user input through the user input unit 150 or via input through interface 170.
  • the blood glucose measurement procedure proceeds to step 1020 in which the blood glucose value is measured.
  • This blood glucose measurement step 1020 includes that the blood glucose value is determined and transformed to a blood glucose value data which is forwarded to the storage unit 130 and stored in relation with the time and date indicating when the measurement has been made.
  • the user may mark this blood glucose value data as FBG value data or other blood glucose value data.
  • the blood glucose measurement procedure proceeds to step 1030, in which it is detected, whether the measurement is a FBG measurement or any other blood glucose measurement.
  • the blood glucose measurement procedure is a FBG measurement.
  • this detection is based on the time of day.
  • the medical device is automatically switched to the FBG measurement mode if the blood glucose measurement procedure is performed at morning time.
  • the FBG measurement mode is detected via other parameters or defined via user input. In the latter case, the user is requested to select the respective mode.
  • the blood glucose measurement procedure proceeds to step 1020.
  • the blood glucose measurement procedure proceeds to step 1040 for determining the dose to be administered.
  • the blood glucose measurement procedure proceeds to the physical activity calculation step 1035.
  • Step 1035 a measure of physical activity of the user is calculated.
  • Step 1035 of Figure 8 involves the determining unit 140 reading the data from the storage unit 130 that was provided by the determining unit 140 based on the data provided by the one or more activity sensors 180.
  • Step 1035 may involve disregarding data that is not relevant to those calculations. For instance, it may involve disregarding data that is sufficiently old that it is not significant to the dose of insulin required by the user. It may also involve disregarding data that relates to times prior to the last insulin administration, since that physical activity might be considered to have been accommodated already in the user's medication.
  • Step 1035 may involve processing the data that is not disregarded in any suitable way. For instance 1035 may involve simply calculating the sum of the product of activity intensity and duration, or put another way calculating the area under the graph in Figure 7. This is simple to achieve, but the resulting measure of psychical activity may be less useful than measures provided through more sophisticated calculations.
  • step 1035 may involve summing the product of activity intensity with respect to time, however weighting the products so that higher intensity activities are given more prominence. For instance, high intensity activities such as running may be weighted so as to cause them to contribute to more to the output measure than would result from the simple indication of activity intensity provided by the data stored in the storage unit 130. Alternatively or in addition, a higher weighting may be given to more recent exercise.
  • the fourth period of activity 74 may be weighted such that a measure provided by the step 1035 incorporates a larger contribution by the fourth period activity 74 compared to the second period of activities 72 even having regard to the areas under the graphs of those periods of activity.
  • step 1035 may provide plural measures. For instance, it may provide a first measure for the second period of activity 72, a second measure for the third period of activity 73 and a third measure for the fourth period of activity 74.
  • the separate measures may include a measure of the physical activity and an indication of the time at which the activity occurred. For an extended period of activity, such as the fourth period of activity 74, this may indicate the start time, end time or a central time.
  • the operation proceeds to a dose determination step 1040.
  • dose determination step 1040 a dose to be
  • the dose determination is performed using the measure of physical activity provided by step 1035.
  • the exact algorithm is not described here because it will be appreciated to the skilled person how to incorporate user physical activity information into a dose determination in order to calculate a dose of insulin that would be of the highest benefit to the user's health.
  • the user may be asked whether the proposed dose should be maintained or changed to a different value.
  • a dose guidance may be given nevertheless, for example if only a single measurement was not carried out after a long series of measurements, and if the series of measurements didn't show any levels of hypo- or hyperglycemia.
  • a dose recommendation for the dose to be administered may be given based on the previous FBG value or previous FBG values and based on the previous measured or reported other blood glucose values.
  • the substeps of the dose determination step 1040 are illustrated in more detail in Figure 9.
  • FIG. 9 is a flow diagram illustrating the substeps of the dose determination procedure.
  • the blood glucose level is measured and the corresponding blood glucose value determined.
  • the respective blood glucose value data is stored in the storage unit 130 together with the time and date when the blood glucose measurement was performed.
  • the blood glucose measurement is a FBG measurement
  • the stored value is automatically marked as a FBG measurement value.
  • step 1 120 the measured blood glucose value is displayed on the display unit 160, preferably together with the time and date when the measurement was performed.
  • the blood glucose value is a FBG value.
  • the blood glucose value is displayed in units of mg/dl or mmol/l.
  • the dose determination procedure proceeds to step 1 130, in order to run hypoglycemic checks. These hypoglycemic checks will be explained in more detail further below. In the case that the hypoglycemic checks performed in step 1 130 do not come to a negative result, the dose determination procedure proceeds to step 1 140. In step 1 140, the selected algorithm is executed for determining the dose to be
  • step 1 150 guidance is displayed in step 1 150.
  • this guidance includes information about the most recent FBG values and the actual FBG values together with the respective administered doses.
  • the displayed guidance includes information about the actual dose to be administered. The guidance displayed will be explained in more detail further below in context with Figure 10.
  • the dose determined in step 1 140 is accepted by the user, the dose is stored in relation to the time and date when determined in the storage unit 130.
  • the medical device 100 comprises a dose setting unit and a dose delivering unit
  • data representing the dose determined are transmitted to the dose setting unit.
  • data representing the dose to be administered are transmitted to an external dose setting unit and dose delivering unit.
  • Figure 10 is a schematic diagram showing the display of the medical device 100 for an operation mode, as explained in context with step 1 150.
  • the display unit 160 displays the guidance for the user. Preferably, this is the dose to be administered.
  • the functions "confirm” and “change” are assigned to the soft keys 620, so that the user of the medical device 100 can accept the dose determined in step 1 140 or can change it. Alternatively, not only the determined dose is displayed but also the previously administered doses together with the corresponding measured FBG values. Thus, the user of the medical device 100 has additional information for deciding, whether to accept the determined and displayed dose or not.
  • personalization information is displayed in the display unit 160, such as the user name, so that the user can easily identify that the dose has been determined based on the algorithm and parameters selected and personalized for the user.
  • the medical device 100 is connected via a wired or wireless interface to an external dose setting unit, the user is requested whether data corresponding to the displayed units for the dose to be administered shall be transmitted to the dose setting unit.
  • the user confirms the transmission, respective data corresponding to the displayed dose are transmitted to the dose setting unit.
  • all information displayed on the display unit 160 is output via a voice module.
  • the output via the voice module is triggered via a user input.
  • the output via voice module is performed automatically based on a user selection in a setup menu.
  • the information displayed on the display is transmitted to a headset, for instance via Bluetooth.
  • Figure 1 1 is a schematic diagram illustrating the medical device 100 according to a further preferred embodiment of the invention.
  • the medical device 100 comprises a blood glucose measurement unit 1 10, a receiving unit 120, a storage unit 130 and a determining unit 140. Additionally, the medical device 100 comprises a user input unit 150 and a display unit 160, as already shown in Figure 1. Additionally, the medical device 100 shown in Figure 1 1 comprises a transceiver unit 1910 capable to
  • the medical device 100 comprises a further transceiver unit 1920 capable to communicate with the transceiver unit 1910.
  • the transceiver unit 1920 is connected to a dose setting unit 1930 for setting a dose to be administered according to the signals received from the transceiver unit 1920.
  • the dose setting unit is further connected to a dose delivering unit 1940.
  • the transceiver unit 1920, the dose setting unit 1930 and the dose delivering unit 1940 form a functional and structural unit which is separated from the other components shown in Figure 1 1 .
  • the transceiver unit 1920, the dose setting unit 1930 and the dose delivering unit 1940 form an insulin pen or insulin pump or an inhaler device which receives signals from the transceiver unit 1910 which dose has to be set in order to deliver a dose determined by the determining unit 140.
  • the dose setting unit 1930 activates the respective dose setting mechanism for setting the dose according to the received signals.
  • the delivery of the dose to be administered is either activated manually by the user of the medical device 100 or automatically activated. In the case of an insulin pen the activation is preferably done manually by the user. In the case of an insulin pump the activation is preferably done automatically.
  • the dose delivering unit 1940 forwards a signal to the transceiver unit 1920 that the dose set has been successfully delivered.
  • the transceiver unit 1920 transmits the respective signal of the successful delivery of the dose set to the transceiver unit 1910.
  • the successful delivery of the set dose can be protocolled by the determining unit 140 and stored in the storage unit 130.
  • the blood glucose measurement unit 1 10 is a continuous sensor which is e.g. implanted and the dose delivering unit 1940 is an insulin pump an automatic delivery system is provided.
  • this full automatic delivery system asks for a user confirmation in the case of a dose increase a semi closed loop control is provided.
  • the one or more activity sensors 180 are integrated into the medical advice 100.
  • the one or more physical activity sensors 180 are incorporated into a device 1300 that is external to the medical device 100.
  • the external device 1300 includes a transceiver unit 1301 that is operable to
  • the transceiver unit 1301 may take any suitable form, as described above with reference with respect to the transceiver unit 1920 of Figure 1 1 .
  • the external device 1300 also includes an information processing unit 1302.
  • the output of the one or more activity sensors 180 are connected to the information processing unit 1302.
  • the information processing unit 1302 is configured to analyse the data provided by the physical activity sensors 180 and provide information indicative of the activity of the user for transmission to the medical advice 100 by the transceiver unit 1301 . This results in less data being needed to be transmitted by the transceiver unit 1301 , and also requires less processing by determining unit 140 of the medical device 100.
  • the information processing unit 1302 may be configured to indicate the intensity and time of activity performed by the user in the same way as described above with reference to Figure 7, for instance.
  • the external device 1300 may for instance take the form of a sports watch. This may include an accelerometer as one of the one or more physical activity sensors 180.
  • the sports watch 1300 may additionally include a heart rate monitor as one of the physical activity sensors 180.
  • the external device 1300 includes one type of physical activity sensor 180 and the medical device 100 includes another type of physical activity sensor 180.
  • the external device 1300 might include a heart rate monitor 180 and the medical device 100 might include an accelerometer 180.
  • the information processing unit 1302 processes the output of the heart rate monitor 180 in the external device 1300 and provides indicative
  • the determining unit 140 than processes this information in conjunction with accelerometer information provided by the accelerometer 180 in the medical device 100 to produce data indicative of activity undertaken by the user for storage in the storage unit 130.
  • the external device 1300 may alternatively take the form of an exercise machine, for instance a treadmill or exercise bike.
  • the physical activity sensors 180 and the information processing unit 1302 of the external device 1300 may then provide output information in the form of work done by the user and/or power at each of multiple instances of time. Such information can be used by the determining unit 140 to indicate more closely a level of activity undertaken by the user.
  • the physical activity sensors 180 and the information processing unit 1302 of the external device 1300 is this instance can be described as an ergometer.
  • the external device 1300 may alternatively include a pedometer as the activity sensor 180. In this case, the processing required by the information processing unit 1302 is relatively low.
  • the external device 1300 may provide activity information to the medical device 100 as the activity is happening, or it may be transferred periodically, at the end of the period of activity or in response to a user input.
  • the transceiver unit 1301 or the transceiver unit 1910 being a wired unit, e.g. a USB module, information is transferred only when the transceiver units 1301 , 1910 are physically connected together.
  • the medical device 100 is configured to verify that information received from the external device 1300 relates to a user that is registered with the device.
  • the medical device 100 is configured to disregard information other than verified information when calculating the medicament dose.
  • this information can be provided to the user and/or an HCP.
  • the medical device 100 may be configured to show on the display unit 160 the amount of activity completed by the user in the current day. This may be indicated on an absolute level, or may be indicated as a percentage of a target for the user.
  • the medical device 100 may display on the unit 160 after the second period of activity 72 that the user has achieved 80% of their target activity for the day.
  • the determining unit 140 may cause to be displayed on the display unit 160 an indication that the user has achieved 145% of their target activity for the day. Achievement of the target may be accompanied by a reward, for instance a smiley icon or similar.
  • Data indicating the physical activity of the user may be communicated to an HCP's device or computer along with other information such as insulin doses, times of administration etc.
  • the algorithms or dose adjustment profiles are based on several components, such as templates and parameters.
  • algorithms are composed by one or more templates and one or more parameter sets.
  • Figure 13 is a schematic diagram illustrating the relation of the templates with the parameters and the parameter sets according to a preferred embodiment of the invention.
  • the medical device 100 comprises a set of templates 2710, which are already predefined.
  • Each template 2710 comprises an ID, which uniquely identifies the template.
  • each template comprises one or more parameters 2720 and/or one or more parameter sets 2730. These parameters are also identified via a unique identifier.
  • the relation between the template ID and the parameter IDs and parameter set IDs is stored.
  • specific templates are provided for starting the algorithm, for the different phases of the algorithm, for terminating the algorithm, for low FBG rules, for
  • hypoglycemic rules and for intervention rules By composing the different templates via selecting one or more of the specific template a new algorithm can be composed, which comprises the startup of the algorithm, the different phases of the algorithm, the termination of the algorithm together with the low FBG rules, the hypoglycemia rules and the further intervention rules.
  • the templates comprise predefined actions, such as displaying a set of parameters from which a specific parameter has to be selected for personalization, for requesting a value to be input by the user, for displaying a number of checkboxes, which have to be marked by the user, etc.
  • the templates for initializing the algorithm comprise a drop-down menu from which the starting value or current value of the dose is selected or offer a request to the user to enter the value manually.
  • the template for the different phases of the algorithm comprise a drop-down menu or a request for manual input of the titration interval and the dose increase, which is made for each titration interval.
  • the parameter and parameter sets define a specific initial dose value, a specific first dose increase step, a specific first time interval for increasing the dose, a specific first target blood glucose value, a specific second dose increase step, a specific second time interval for increasing the dose, a specific second target blood glucose value, etc., a specific low blood glucose threshold value, a specific low blood glucose dose decrease step, a specific hypoglycemic blood glucose threshold value, a specific hypoglycemic blood glucose dose decrease step, etc.
  • the templates for the rule comprise a list of rules and actions, which are executed in the case that a specific event occurs. This also includes the input of information, such as e- mail addresses to which e.g. an alert is sent.

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Abstract

L'invention concerne un dispositif comprenant: des moyens d'obtention d'un paramètre d'un échantillon de liquide organique provenant d'un utilisateur; des moyens d'utilisation d'informations fournies par un ou plusieurs capteurs pour calculer une mesure de l'activité physique de l'utilisateur ; des moyens de calcul d'une dose de médicament à l'aide au moins en partie du paramètre mesuré et de la mesure de l'activité physique de l'utilisateur ; et des moyens d'indication à l'utilisateur de la dose de médicament calculée.
PCT/EP2012/054561 2011-03-18 2012-03-15 Calcul d'une dose de médicament Ceased WO2012126800A1 (fr)

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JP2013558438A JP6178243B2 (ja) 2011-03-18 2012-03-15 薬剤用量を計算すること
DK12709098.3T DK2685898T3 (da) 2011-03-18 2012-03-15 Beregning af en medikamentdosis
EP12709098.3A EP2685898B1 (fr) 2011-03-18 2012-03-15 Calcul d'une dose de médicament
CA2828077A CA2828077A1 (fr) 2011-03-18 2012-03-15 Calcul d'une dose de medicament
US14/004,768 US10105093B2 (en) 2011-03-18 2012-03-15 Calculating a medicament dose
US16/165,726 US10506972B2 (en) 2011-03-18 2018-10-19 Calculating a medicament dose

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US20190053755A1 (en) 2019-02-21
EP2685898B1 (fr) 2022-09-07
CA2828077A1 (fr) 2012-09-27
US10105093B2 (en) 2018-10-23
US20140005501A1 (en) 2014-01-02
JP6178243B2 (ja) 2017-08-09
EP2685898A1 (fr) 2014-01-22
DK2685898T3 (da) 2022-11-28
JP2014514036A (ja) 2014-06-19
US10506972B2 (en) 2019-12-17

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